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Non-sterile scar management dressing, single-use - ARTG 436834

Access comprehensive regulatory information for Non-sterile scar management dressing, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 436834 and sponsored by Soul Pattinson Manufacturing Pty Ltd, manufactured by Winner Medical Co Ltd in China. The device registration started on January 23, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class I
ARTG 436834
Class I
Non-sterile scar management dressing, single-use
ARTG ID: 436834
Good Name: Soul Pattinson Manufacturing Pty Ltd - Non-sterile scar management dressing, single-use
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Intended Purpose

Intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
436834
Start Date
January 23, 2024
Effective Date
January 23, 2024
Manufacturer
Country
China
Address
Winner Industrial Park No 660 Bulong Road, Longhua District, Shenzhen, 518109